Ranbaxy Laboratories has sued USFDA over revoking an approval to sell generic versions of two drugs -- digestive disorder medicine Nexium and anti-viral Valcyte-- in the US market.
When contacted, a spokesperson of the USFDA said: "The FDA does not comment on pending litigation." Ranbaxy officials in India declined to comment saying the matter concerned legal issues in the US.
As per the lawsuit filed in the US District Court of Columbia the company "seeks immediate judicial review" of a November 4 decision of the US Food and Drug Administration (USFDA) that stripped Ranbaxy of "its statutory rights" and "literally hundreds of millions of dollars in anticipated revenues for certain generic versions of the brand-name drugs Nexium and Valcyte".
While revoking Ranbaxy's approval for the two drugs, the USFDA had cited adverse compliance status of Ranbaxy's Paonta and Dewas facilities and it was "accordingly ...Correcting its mistake and rescinding the tentative approval letters issued regarding these ANDAs".
In 2008, Ranbaxy was granted approval by the USFDA to sell its generic copies in select doses of Astrazaneca's Nexium and Roche's Valcyte each with 180-day generic marketing exclusivity as and when the patents of the two branded drugs expired.
However, the company had run into trouble with the USFDA cracking down on it for failure to observe current GMPs (good manufacturing practices) at its Dewas and Paonta facilities. Last year it had agreed to pay USD 500 million as settlement with US authorities after admitting to "felony charges" following a consent decree it had signed earlier.
Ranbaxy, however, in its suit said the USFDA "has no power to correct an alleged 'mistake' it made six years ago".
"Nothing in the FDCA permits FDA to revoke the issuance of a tentative approval and even if the agency did have such authority, it was not timely exercised here".
Nor did the agency make a mistake in any event: USFDA not only was aware of the relevant facilities' compliance issues at the time it granted tentative approval (TA) to Ranbaxy's ANDAs, but senior FDA officials, including those at the highest levels, considered and determined that those products were eligible for TA despite the known compliance issues at the relevant facilities, the company said in its petition.
